Repository Corticotropin (Acthar Gel) — Utilization Management
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Defines prior authorization, coverage criteria, dosing, and non-coverage conditions for Acthar Gel for members of Aspirus Medicare Plans, and directs prescribing by or in consultation with specialists.
No material clinical or coverage changes in this revision.
Coverage Criteria
Infantile Spasms — Initial Therapy
Covered when ALL of the following are met:
Acthar Gel single-dose prefilled SelfJect injector (subcutaneous) should not be approved for infantile spasms.
Coverage of Acthar Gel is not recommended for the following conditions: ankylosing spondylitis; dermatomyositis or polymyositis; diabetic nephropathy; glomerular kidney diseases (including nephrotic syndrome, membranous nephropathy, IgA nephropathy, minimal change disease, infection‑related glomerulonephritis, focal segmental glomerulosclerosis, and membranoproliferative glomerulonephritis); gout; juvenile idiopathic arthritis; lupus nephritis; multiple sclerosis, acute exacerbations; ophthalmic conditions (e.g., acute optic neuritis, keratitis, retinal vasculitis); psoriatic arthritis; rheumatoid arthritis; sarcoidosis; and for circumstances not listed in the Recommended Authorization Criteria.
Use of Acthar Gel for the conditions listed above is not recommended for coverage because clinical guidelines and specialty society recommendations generally do not identify ACTH (repository corticotropin) as a standard therapy for these diseases, and high‑quality evidence supporting its use is lacking. Examples include guideline statements that do not cite ACTH for ankylosing spondylitis, idiopathic inflammatory myopathies, gout, juvenile idiopathic arthritis, psoriatic arthritis, and rheumatoid arthritis; KDIGO and other renal guidelines that do not endorse ACTH for glomerular diseases or lupus nephritis; and limited data for ophthalmic conditions and sarcoidosis, where repository corticotropin is suggested only after failure of recommended therapies. Requests for Acthar for these indications may therefore be denied.
Coding and Dosing
| J0800 | Repository corticotropin, porcine, 1 mg (example billing code — policy does not list explicit codes; include common HCPCS used for Acthar) |
Provider Actions and Authorization
Prior authorization required for Acthar Gel
Prior authorization is required for Acthar Gel; approval is recommended only when the patient meets the specified authorization criteria (e.g., infantile spasms criteria). Approval requires that Acthar be prescribed by or in consultation with a physician who specializes in the condition being treated. Requests for doses outside the dosing documented in this policy will be reviewed case‑by‑case by a clinician.
- Prior authorization recommended for prescription benefit coverage of Acthar Gel.
- Approvals provided only when all applicable Criteria and Dosing are met.
- Doses outside established dosing will be considered case‑by‑case by a Medical Director or Pharmacist.
Step therapy guidance — reserve repository corticotropin for refractory cases
No formal step therapy algorithm is specified in this policy. Clinical guidelines (for example, sarcoidosis guidance) recommend reserving repository corticotropin for patients who have failed prior treatments, so consider Acthar only after standard therapies are ineffective or not tolerated.
- Policy does not define a stepwise prior authorization sequence.
- Guidelines (European Respiratory Society for sarcoidosis) recommend reserving repository corticotropin for patients who have failed prior treatments (e.g., steroids, antimetabolites).
Required documentation to support authorization
Prescriber must document key clinical details supporting use: patient age, route of administration, prescriber specialty/consultation, dosing, and formulation.
- Document that the child is less than 2 years of age for infantile spasms.
- Document intramuscular route of administration for infantile spasms and that the multidose vial (not SelfJect) is being used.
- Record that the medication is prescribed by or in consultation with a physician who specializes in neurology, and record the dosing (up to 150 units/m2/day for up to 1 month).
Denial triggers — indications not recommended for approval
Requests for Acthar for indications listed under 'Conditions Not Recommended for Approval' or for circumstances not included in the Recommended Authorization Criteria are not recommended for coverage and may be denied.
- Do not submit requests for conditions specifically listed as not recommended (e.g., ankylosing spondylitis, lupus nephritis, multiple sclerosis acute exacerbations, sarcoidosis, psoriatic arthritis, rheumatoid arthritis, ophthalmic conditions, and various glomerular kidney diseases).
- Requests for circumstances not listed in the Recommended Authorization Criteria may be denied.
Product Definitions
Background
Acthar Gel is a repository corticotropin (an ACTH analog) available for intramuscular or subcutaneous administration. It is indicated for infantile spasms (treatment in infants) and has been used in other settings such as multiple sclerosis exacerbations, but guideline support and evidence vary by indication. For the treatment of infantile spasms, the policy requires use of the multidose vial given by intramuscular injection; the single‑dose prefilled SelfJect subcutaneous injector is intended for adult doses and should not be used for infantile spasms. Dosing guidance for infantile spasms supports approval up to 150 units/m2/day IM for up to 1 month when criteria are met.
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